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A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

19 de diciembre de 2012 actualizado por: Hoffmann-La Roche

A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer

This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

2611

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • female patients 18-70 years of age;
  • adenocarcinoma of the breast;
  • previous invasive breast cancer if diagnosed >5 years before entering study;
  • no evidence of metastatic disease.

Exclusion Criteria:

  • history of severe hypersensitivity reaction to Taxotere;
  • previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
  • treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Droga: capecitabina [Xeloda]
825 mg/m2 po bid en los días 1-14 de cada ciclo de 3 semanas
Droga: Taxotere
75 mg/m2 iv el día 1 de cada ciclo de 3 semanas
Droga: Taxotere
100mg/m2 iv on day 1 of each 3 week cycle
Comparador activo: 2
Droga: Taxotere
75 mg/m2 iv el día 1 de cada ciclo de 3 semanas
Droga: Taxotere
100mg/m2 iv on day 1 of each 3 week cycle

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Disease Free Survival [Number of Events]
Periodo de tiempo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Number of patients with/without recurrence of breast cancer, or death due to any cause.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival [Time to Event]
Periodo de tiempo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival [Number of Events]
Periodo de tiempo: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Number of patients who died/were alive.
Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Overall Survival [Time to Event]
Periodo de tiempo: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.
Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Breast Cancer Free Survival [Number of Events]
Periodo de tiempo: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.
Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
Breast Cancer Free Survival [Time to Event]
Periodo de tiempo: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
Periodo de tiempo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
Periodo de tiempo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Number of Events]
Periodo de tiempo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Time to Event]
Periodo de tiempo: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hoffmann-La Roche

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2002

Finalización primaria (Actual)

1 de junio de 2010

Finalización del estudio (Actual)

1 de mayo de 2012

Fechas de registro del estudio

Enviado por primera vez

5 de agosto de 2004

Primero enviado que cumplió con los criterios de control de calidad

5 de agosto de 2004

Publicado por primera vez (Estimar)

6 de agosto de 2004

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de diciembre de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

19 de diciembre de 2012

Última verificación

1 de diciembre de 2012

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NO17629

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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